Phase III data showed the therapy reduced hemolysis and improved fatigue, overall quality of life and anemia 12/07; Phase III data showed it improved fatigue 6/08

Phase III PRIMO-CABG2 showed benefit but not statistical significance in reducing myocardial infarction or death through 30 days following coronary bypass graft surgery 11/05; Phase III APEX-AMI trial did not reduce with statistical significance mortality at 30 days following primary percutaneous coronary intervention or angioplasty 6/06

Phase III failed to achieve endpoint but exceeded criteria for success on accuracy and sensitivity 5/07; submitted an NDA 4/08; NDA was accepted for review 6/08; data showed incremental predictive value 11/08; FDA panel voted against it, saying efficacy data are not sufficient to justify risk 12/08

Phase III data showed the drug failed statistically any clincally relevant PAD parameters 11/07

Approved in the European Union 8/08

The molecule is moving into a Phase III program following Phase II data 12/06

Phase IIb dose-finding study hemorrhage reached statistical significance at all three doses 6/06; company is moving it into a pivotal Phase III trial 11/07

FDA accepted for filing the NDA 3/08

Began Phase III trial (Study XP052) to evaluate safety and efficacy in 200 patients 3/06; drug met its endpoints in the first of three Phase III studies 4/07; pivotal study showed it significantly improved the symptoms of moderate to severe primary restless leg syndrome compared to placebo 4/08; submitted an NDA 9/08

Received an approvable letter from the FDA 7/08

Began two pivotal Phase III trials 11/07; Began a six-month extension study 1/08; completed enrollment in the EQUATE and EQUIP studies 3/08; completed enrollment in the last of three Phase III studies 4/08

Top-line Phase III data showed it hit the primary endpoint by significantly improving short-term sleep onset 6/08

Completed enrollment in the first of two Phase III trials 8/07; Phase III data showed statistically significant results for primary efficacy endpoints that will support drug marketing applications in the U.S. and Europe 2/08; trial demonstrated that it significantly reduced the number of seizures in adults 12/08

FDA approved an extended-release version to treat partial onset seizures in patients 16 years or older 9/08; data showed patients taking it once daily had lower rates of some adverse events vs. levetiracetam IR twice daily 12/08

FDA accepted for filing an sNDA 12/07; CHMP recommended that the European Commission grant marketing authorization 4/08; received complete response letter to the sNDA 12/08

Phase III data showed that both the 3.5-mg and 1.75-mg doses demonstrated highly statistically significant results in non-elderly adult patients 6/07

Began a Phase III program 6/08; enrolled the first patient in the Phase III registration trial 9/08

Completed all pivotal and supporting clinical trials; the Phase III trial met its primary end-point 6/08; data demonstrated that the 1.75-mg and 3.5-mg doses shortened the time for patients to return to sleep compared to placebo 10/08; submitted an NDA 10/08; FDA accepted for review the NDA 12/08

Began Phase III trial to evaluate safety and efficacy vs. placebo in 150 patients 10/06; controlled addiction better than placebo for a full six months in a Phase III study 7/08; data showed a clinically and statistically significant difference over placebo 11/08